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NCT ID: NCT03334747 Completed - Malaria Clinical Trials

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.

NCT ID: NCT03315962 Completed - Tuberculosis Clinical Trials

Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

SEARCH-IPT
Start date: November 15, 2017
Phase: N/A
Study type: Interventional

The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) and additional leadership and management training that targets District Health Officers (DHOs) can increase IPT initiation among HIV-infected persons, as compared to country standard practices, in a cluster randomized trial in Uganda.

NCT ID: NCT03307226 Completed - HIV/AIDS Clinical Trials

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Start date: March 23, 2018
Phase: N/A
Study type: Interventional

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

NCT ID: NCT03302299 Completed - Tuberculosis Clinical Trials

Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)

ADEPTT
Start date: April 7, 2017
Phase: Phase 4
Study type: Interventional

The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the safety and tolerability of 6H overall and by level of alcohol use. The second aim is to estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months. Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The study will actively monitor for hepatotoxicity using the U.S. standard of care for TB preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are detected. The investigators will use the safety, tolerability, and adherence results, together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA, and an established decision analytic model of TB preventive therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study will additionally follow the cohort every 6 months after completing INH to monitor drinking and the development of active TB.

NCT ID: NCT03282799 Completed - Contraception Clinical Trials

Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the frequency of ovulation and cervical mucus quality of HIV-infected women on efavirenz (EFV)-based antiretroviral therapy (ART) using either a single etonogestrel (ENG) implant or two ENG implants for at least one year.

NCT ID: NCT03258073 Completed - Clinical trials for Maternal, Pediatric Care Emergencies

Does Simulation Scenario Execution Improve Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies?

SimForLife
Start date: August 30, 2017
Phase: N/A
Study type: Interventional

In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.

NCT ID: NCT03249181 Completed - Pregnancy Related Clinical Trials

Dolutegravir in Pregnant HIV Mothers and Their Neonates

DolPHIN-2
Start date: January 22, 2018
Phase: Phase 3
Study type: Interventional

To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy. An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women commencing cART in late pregnancy. HIV positive pregnant women presenting with untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV + 2 NRTIs (SoC)

NCT ID: NCT03203200 Completed - Clinical trials for Sexually Transmitted Infection

A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers

ZETRA
Start date: August 24, 2015
Phase: N/A
Study type: Interventional

This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.

NCT ID: NCT03167879 Completed - Clinical trials for Safer Conception Intervention Trial

Integrating Safer Conception Counseling to Transform HIV Family Planning Services

Start date: June 15, 2017
Phase: N/A
Study type: Interventional

This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family planning (FP) program that incorporates a structured, multi-component safer conception counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2; less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by The AIDS Support Organization (TASO) Uganda.

NCT ID: NCT03167242 Completed - Clinical trials for Acute Uncomplicated Plasmodium Falciparum Malaria

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated Plasmodium falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.